Medical Device Manufacturer · US , Naples , FL

Arthrex, Inc. - FDA 510(k) Cleared Devices

346 submissions · 342 cleared · Since 1992
346
Total
342
Cleared
0
Denied
307 devices
176-200 of 307
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Orthopedic · 115d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Orthopedic · 210d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Orthopedic · 42d
Cleared May 31, 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · KWS
Orthopedic · 134d
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · MBI
Orthopedic · 70d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241 · HRS
Orthopedic · 170d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Orthopedic · 51d
Cleared Mar 20, 2012
BIOBOLT
K120540 · MAI
Orthopedic · 26d
Cleared Mar 08, 2012
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
K120044 · KWS
Orthopedic · 63d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Orthopedic · 30d
Cleared Dec 21, 2011
ARTHREX FRACTURE SYSTEM
K112437 · HTN
Orthopedic · 119d
Cleared Dec 19, 2011
ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
K112990 · HTY
Orthopedic · 74d
Cleared Dec 15, 2011
ARTHREX BIOCOMPOSITE TRANSFIX
K112040 · MAI
Orthopedic · 150d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237 · HWC
Orthopedic · 29d
Cleared Aug 19, 2011
ARTHREX SCAPHOLUNATE ANCHOR
K111661 · MBI
Orthopedic · 66d
Cleared Aug 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253 · HRS
Orthopedic · 90d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123 · HTY
Orthopedic · 100d
Cleared Mar 31, 2011
ARTHREX BIOCOMPOSITE SUTURETAK
K110660 · MAI
Orthopedic · 24d
Cleared Mar 18, 2011
LOW PROFILE SCREWS
K103705 · HWC
Orthopedic · 88d
Cleared Jan 07, 2011
ARTHREX SWIVELOCK ANCHORS
K101823 · MAI
Orthopedic · 191d
Cleared Jan 05, 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · MBI
Orthopedic · 79d
Cleared Dec 28, 2010
ACL TIGHTROPE DOUBLE BUNDLE
K101837 · HTY
Orthopedic · 180d
Cleared Dec 22, 2010
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466 · KWS
Orthopedic · 28d
Cleared Oct 22, 2010
ARTHREX PUSHLOCK ANCHORS
K101679 · MAI
Orthopedic · 129d
Cleared Jun 23, 2010
ACL TIGHTROPE
K100652 · HTY
Orthopedic · 107d

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